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Psychedelic
Psilocybin for Healthy Subjects
Phase 1 & 2
Recruiting
Led By Frederick S Barrett, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 to 75 years old
Have at least a high-school level of education or equivalent and be fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will use EEG and MRI to study how psilocybin, a compound in some mushrooms, affects thoughts and brain activity.
Who is the study for?
Participants must be healthy adults aged 18-75, vaccinated against COVID-19, fluent in English with at least high school education. They should have prior experience with psychedelics and agree to avoid psychoactive substances and certain medications before sessions. Pregnant or nursing women, individuals with cardiovascular issues, epilepsy, diabetes on insulin, psychiatric disorders or those taking serotonergic medications are excluded.Check my eligibility
What is being tested?
The study examines the effects of psilocybin versus a placebo on thought processes and brain activity using EEG and MRI scans. Participants will perform computerized tasks while their brain responses are monitored to understand how this psychedelic compound affects them.See study design
What are the potential side effects?
Psilocybin can cause altered sensory experiences and perception changes, confusion, emotional shifts ranging from euphoria to distress, potential anxiety or panic reactions during use. Long-term side effects are not well understood but could include persistent changes in perspective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have completed high school or equivalent and am fluent in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy in the alternative uses task
Accuracy in the remote associates task as assessed by total correct number of trials
Alpha band power in EEG record
+3 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Psilocybin FirstExperimental Treatment2 Interventions
Psilocybin (10mg) will be administered one time orally as a capsule taken with water. Expected duration of acute effects is approximately 6 hours. After a period of a washout, participants will switch to the placebo intervention.
Group II: Placebo FirstPlacebo Group2 Interventions
Participants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water. After a period of a washout, participants will switch to the Psilocybin intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Psilocybin
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,750 Total Patients Enrolled
Frederick S Barrett, PhDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
103 Total Patients Enrolled
Frederick S BarrettPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I have diabetes that requires insulin or have had low blood sugar with diabetes pills.I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.My weight is within 20% of the ideal range for my height.I have epilepsy with a history of seizures.I have not had serious heart issues or uncontrolled high blood pressure in the past year.I regularly take medication that affects serotonin in my brain.I regularly take prescription medication for my mental health.I have completed high school or equivalent and am fluent in English.I have a history of recurring headaches.I am between 18 and 75 years old.I agree not to take any over-the-counter meds, supplements, or herbs a week before each drug session unless approved.A close family member has bipolar I, schizophrenia, or another psychotic disorder.I have completed high school or equivalent and am fluent in English.I've had a head injury that knocked me out for more than 2 minutes.I agree not to take any erectile dysfunction medication 72 hours before each treatment.I do not have a psychiatric condition that makes psilocybin unsafe for me.I am healthy and mentally stable, confirmed by medical exams and tests.I agree not to take any non-prescribed drugs or supplements before drug sessions, except for approved exceptions.You have used certain drugs that cause hallucinations (such as LSD, mushrooms, or ayahuasca) at least five times in your life.I agree not to take any erectile dysfunction medication 72 hours before each treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo First
- Group 2: Psilocybin First
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05301608 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who would be most likely to see benefits from participating in this trial?
"The ideal candidate for this study would be a healthy individual aged 18-75. Right now, the team is looking to enroll 6 patients in total."
Answered by AI
Are people with the relevant medical condition able to participate in this trial?
"No, this study is not currently enrolling new patients. Although the trial was last updated on August 29th 2022, it is presently inactive. There are 895 other trials that potential participants could look into."
Answered by AI
For this test, are elderly patients being accepted?
"The age range for patients that are being recruited for this study are between 18-75 years old."
Answered by AI
Who else is applying?
What state do they live in?
New York
Pennsylvania
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Johns Hopkins Center for Psychedelic and Consciousness Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Im just curious. Interested in the study. I'm interested in any clinic trial.
PatientReceived no prior treatments
I am curious about psilocybin and it’s benefits. I am fascinated by the possible medical uses of psilocybin.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
What is the time commitment? How often do I have to be at JH? How many sessions at John’s Hopkins will the clinical trial involve?
PatientReceived 2+ prior treatments
How many visits to the center will be required and how long are the visits?
PatientReceived 1 prior treatment
I am available on Mondays and Tuesdays only. Is this a disqualifying condition?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Johns Hopkins Center for Psychedelic and Consciousness Research: < 24 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
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